Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke (MOONRISE)

• ClinicalTrials.gov Identifier: NCT05525325
• Recruitment Status: Recruiting
• First Posted: September 1, 2022
• Last Update Posted: May 8, 2024
• Sponsor: University Hospital Heidelberg
• Information provided by (Responsible Party): Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

Study Description

Brief Summary:

Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia

Condition or disease	Intervention/treatment	Phase
Stroke Thrombectomy	Procedure: General Anesthesia	Not Applicable

Detailed Description:

Endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. Several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. While much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. The majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. A few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. Here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a PROBE (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke
• Actual Study Start Date: October 1, 2022
• Estimated Primary Completion Date: October 2026
• Estimated Study Completion Date: January 2027

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: General Anesthesia Group; Patients randomized to the GA arm are intubated after anesthetic induction.	Procedure: General Anesthesia; Patients randomized to the GA arm are intubated after anesthetic induction. For this purpose, they are pre-oxygenated with an oxygen mask and non-invasive monitoring is established. After sufficient pre-oxygenation has been applied, analgesic and sedative medication are administered. If the patient is sufficiently long nil by mouth they are manually ventilated before a muscle relaxant is administered. A rapid-sequence induction is performed with administration of an opioid, sedative and muscle relaxant in rapid succession and without intermediate manual ventilation in non-nil by mouth patients. To secure the airway, an endotracheal tube is inserted into the trachea with the aid of a laryngoscope. After insertion of the endotracheal tube, its endotracheal position is confirmed with auscultation and capnography. GA maintenance therapy with opioids, sedatives and catecholamines, if needed, will then be started.
Experimental: Procedural Sedation Group; After randomization into the PS arm, the need for analgesics or sedatives are evaluated clinically.	Procedure: General Anesthesia; Patients randomized to the GA arm are intubated after anesthetic induction. For this purpose, they are pre-oxygenated with an oxygen mask and non-invasive monitoring is established. After sufficient pre-oxygenation has been applied, analgesic and sedative medication are administered. If the patient is sufficiently long nil by mouth they are manually ventilated before a muscle relaxant is administered. A rapid-sequence induction is performed with administration of an opioid, sedative and muscle relaxant in rapid succession and without intermediate manual ventilation in non-nil by mouth patients. To secure the airway, an endotracheal tube is inserted into the trachea with the aid of a laryngoscope. After insertion of the endotracheal tube, its endotracheal position is confirmed with auscultation and capnography. GA maintenance therapy with opioids, sedatives and catecholamines, if needed, will then be started.

Outcome Measures

Primary Outcome Measures :

1. Functional outcome as measured by modified Ranking Scale (mRS) after admission. [ Time Frame: 90 days +/- 2 weeks ]
   0-6; higher mean worse outcome

Secondary Outcome Measures :

1. Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission [ Time Frame: [NIHSS on admission - NIHSS after 24 hours] ]
   0-42 points; higher mean worse outcome
2. Mortality [ Time Frame: intra-hospital until discharge up to 2 weeks [yes/no] and over the whole follow-up period up to 3 months [time to event] ]
   cerebral or non-cerebral cause of death
3. Postinterventional pc-ASPECTS, determined with CT or MRI post-interventional follow up scan [ Time Frame: 12-36 hours after admission ]
   semi-quantitative method for grading irreversible ischemia in the vertebrobasilar system; 0-10 points; lower mean higher infarct volumes
4. Feasibility of EST [ Time Frame: duration of thrombectomy procedure in minutes ]
   e.g. necessity of intubation, cardio-respiratory stability, loss in level of consciousness, loss of cough reflex, vomiting
5. Complications before/during and after EST [ Time Frame: duration of the whole hospital stay in days ]
   e.g. severe agitation, loss of level of consciousness, loss of cough reflex, vomiting, cardio-respiratory stability

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
2. Age 18 years or older, either sex
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 4
4. Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA)
5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure)

Exclusion Criteria:

1. Intracerebral hemorrhage
2. Coma on admission (Glasgow Coma Scale ≤ 8)
3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
4. Intubated state before randomization
5. Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)

Contacts and Locations

Contacts

Contact: Min Chen, MD; 0049/6221/7504; min.chen@med.uni-heidelberg.de

Locations

Germany

Department of Neurology, University Hospital Heidelberg; Recruiting

Heidelberg, Baden-Württemberg, Germany, 69120

Contact: Silvia Schönenberger, Dr. 0049-6221-5637549 silvia.schoenenberger@med.uni-heidelberg.de

Sub-Investigator: Silvia Schönenberger, Dr.

Sponsors and Collaborators

University Hospital Heidelberg

Investigators

• Principal Investigator: Silvia Schönenberger, MD; University Hospital Heidelberg
• Principal Investigator: Min Chen, MD; UUHeidelberg

More Information

Publications of Results:

Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455. Erratum In: JAMA. 2019 Dec 24;322(24):2445.

Other Publications:

Jadhav AP, Bouslama M, Aghaebrahim A, Rebello LC, Starr MT, Haussen DC, Ranginani M, Whalin MK, Jovin TG, Nogueira RG. Monitored Anesthesia Care vs Intubation for Vertebrobasilar Stroke Endovascular Therapy. JAMA Neurol. 2017 Jun 1;74(6):704-709. doi: 10.1001/jamaneurol.2017.0192.

Weyland CS, Chen M, Potreck A, Jager LB, Seker F, Schonenberger S, Bendszus M, Mohlenbruch M. Sedation Mode During Endovascular Stroke Treatment in the Posterior Circulation-Is Conscious Sedation for Eligible Patients Feasible? Front Neurol. 2021 Sep 17;12:711558. doi: 10.3389/fneur.2021.711558. eCollection 2021.

• Responsible Party: Dr. Silvia Schönenberger, MD, Head of Section of Neurointensive Care, University Hospital Heidelberg
• ClinicalTrials.gov Identifier: NCT05525325
• Other Study ID Numbers: MOONRISE
• First Posted: September 1, 2022
• Last Update Posted: May 8, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs